MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01G06-11
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed visible smoke coming from the architect c8000 processing module printer while it was troubleshooting the printer jams.The power was removed from the printer and no signs of fire was observed.The customer stopped using the printer and mentioned the smoke was small and temporary and limited to the printer.No impact to patient management or impact to user safety was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The architect c8000 processing module service history review revealed no additional tickets associated with smoke.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.Data and information provided by the customer were reviewed and support the complaint issue.A review of complaint and trending data for the architect c8000 processing module did not identify any similar issues related to the current issue.Additionally review of complaint and trending data associated with the arc printer 110v did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances and potential non-conformances related to the current issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c8000 processing module for serial number c804481 or the arc printer 110v was identified.
Event or Problem Description
The customer observed visible smoke coming from the architect c8000 processing module printer while it was troubleshooting the printer jams.The power was removed from the printer and no signs of fire was observed.The customer stopped using the printer and mentioned the smoke was small and temporary and limited to the printer.No impact to patient management or impact to user safety was reported.

• Brand Name: ARCHITECT C8000 PROCESSING MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23778495
• Report Number: 3016438761-2025-00717
• Device Sequence Number: 10117448
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01G06-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC PRINTER 110V, 07D08-18, UNKNOWN; ARC PRINTER 110V, 07D08-18, UNKNOWN
• Patient Sex: Unknown